Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

• ClinicalTrials.gov Identifier: NCT02514122
• Recruitment Status: Completed
• First Posted: August 3, 2015
• Results First Posted: November 9, 2018
• Last Update Posted: November 9, 2018
• Sponsor: University of Saskatchewan
• Collaborator: National University, Rwanda
• Information provided by (Responsible Party): William McKay, University of Saskatchewan

Tracking Information

• First Submitted Date: July 31, 2015
• First Posted Date: August 3, 2015
• Results First Submitted Date: May 12, 2017
• Results First Posted Date: November 9, 2018
• Last Update Posted Date: November 9, 2018
• Study Start Date: June 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2018)

Postoperative Pain as Measured on a 11-point Numerical Rating Scale [ Time Frame: The average of twice daily pain scores, from end of surgery until 60 hours postoperative. ]

Pain will be measured using an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable) units on a scale.

Original Primary Outcome Measures (submitted: July 31, 2015)

Postoperative Pain relief [ Time Frame: 60 hours ]

Pain will be measured using an 11-point numerical rating scale

Current Secondary Outcome Measures (submitted: November 6, 2018)

Hallucination [ Time Frame: From end of surgery until 60 hours postoperative. ]

Presence (or not) of hallucinations.

Original Secondary Outcome Measures (submitted: July 31, 2015)

Drug Side effects [ Time Frame: 60 hours ]

Presence of significant side effects

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
• Official Title: Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda: a Randomized Control Trial
• Brief Summary: A randomized double blind control trial to investigate the safety and efficacy of subcutaneous ketamine for control of post operative pain in low resource settings.
• Detailed Description: A randomized double blind control trial. All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries at the Centre Hospitalier Universitaire de Kigali, Kigali, Rwanda will be invited to participate. Enrolled patients will receive subcutaneous ketamine (or placebo) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg. The primary outcome will be a reduction in mean Pain Scores using parametric statistical analysis to discriminate significance. Pain will be measured using an 11-point numerical rating scale. Secondary outcomes will be the presence of significant side effects. This trial is a partnership between the University of Saskatchewan and the National University of Rwanda with ethics approval from each institutions ethics board.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Post Operative Pain
• Pain

Intervention

• Drug: Ketamine
  Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.
• Drug: Saline
  Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.

Study Arms

• Experimental: Ketamine
  Participants will receive subcutaneous ketamine (1mg/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg.
  Intervention: Drug: Ketamine
• Placebo Comparator: Saline
  Participants will receive subcutaneous saline (0.02cc/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.
  Intervention: Drug: Saline

• Publications *: Sacevich C, Semakuba B, McKay WP, Thakore S, Twagirumugabe T, Nyiligira J. Subcutaneous ketamine for postoperative pain relief in Rwanda: a randomized clinical trial. Can J Anaesth. 2018 Feb;65(2):170-177. doi: 10.1007/s12630-017-1009-7. Epub 2017 Nov 13.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2018): 61
• Original Estimated Enrollment (submitted: July 31, 2015): 25
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

- All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries during a one month period with expected post operative hospital admission

Exclusion Criteria:

• Allergy to Ketamine
• History of narcotic abuse or dependence
• Those patients for which decreased cognitive function is a barrier to accurate data collection

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Rwanda

Administrative Information

• NCT Number: NCT02514122
• Other Study ID Numbers: Bio# 14-193
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: IPD will not be shared.

• Current Responsible Party: William McKay, University of Saskatchewan
• Original Responsible Party: University of Saskatchewan
• Current Study Sponsor: University of Saskatchewan
• Original Study Sponsor: Same as current
• Collaborators: National University, Rwanda

Investigators

• Principal Investigator: William Mckay, MD; University of Saskatchewan

• PRS Account: University of Saskatchewan
• Verification Date: November 2018